This Program Announcement expires on October 5, 2003, unless reissued.

NEUROTECHNOLOGY RESEARCH, DEVELOPMENT, AND ENHANCEMENT

Release Date:  October 2, 2001

PA NUMBER:  PA-02-003 (Replaced by PA-04-006)

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov/)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke
 (http://www.ninds.nih.gov/)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)
National Institute on Aging
 (http://www.nih.gov/nia)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
https://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The purpose of this Program Announcement (PA) is to encourage submission of 
new research project grant (R01) and exploratory/developmental research grant 
(R21) applications to research and develop innovative technologies, 
methodologies, or instrumentation for basic or clinical studies of the brain 
in human or non-human animals.  Also solicited are applications for support 
to research, development, and significant enhancements to existing 
technologies important to understanding the brain. 

This Program Announcement replaces PA-98-050. 

HEALTHY PEOPLE 2010 

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS 
led national activity for setting priority areas.  This PA, Neurotechnology 
Research, Development, and Enhancement, is related to one or more of the 
priority areas.  Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS 

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators. 

MECHANISM OF SUPPORT 

This PA will use the National Institutes of Health (NIH) research project 
grant (R01) and exploratory/development grant (R21) award mechanisms.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for a 
research project grant (R01) application submitted in response to this PA may 
not exceed 5 years.  Exploratory/developmental grants (R21) are limited to 2 
years for up to $100,000 per year for direct costs; R21 grants are most 
appropriate for highly innovative research projects with little or no 
preliminary data.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001). 
Additional information on Modular Grants can be found at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

In biomedicine, new tools and approaches often make possible quantum advances 
in research on health and disease, and sometimes shift the manner in which 
such research is undertaken, and results interpreted.  Conversely, the 
complexity of living systems represent interesting challenges to researchers, 
providing ample opportunity for testing and expanding the limits of their 
science and technology.

One of the most complex systems in biomedicine is the brain.  Despite this, 
neuroscience is rapidly advancing, with important discoveries coming to light 
almost daily.  These discoveries will improve understanding of healthy brain 
function and offer promise to the millions suffering from brain disorders of 
all types.  This program announcement seeks to enable neuroscience research 
by soliciting research and development of novel tools and approaches for the 
study of the development, structure, and function of the brain.  Such tools 
could include those used for clinical assessment, diagnosis, and treatment of 
brain disorders.  Significant enhancements of existing technologies are also 
solicited.  Research solicited under this program announcement is not limited 
to any particular type of technology, level of analysis, or approach.  
Multidisciplinary teams of researchers are encouraged to apply.

Technologies appropriate for study, development and enhancement under this PA 
include hardware, software, and wetware (and combinations of thereof) that 
would be used to study the brain in basic or clinical research.  The research 
topics identified here represent examples of technologies that are 
appropriate for this solicitation.  These examples are not a complete list of 
the neurotechnology sought; they are intended only as a guide for determining 
the appropriateness of a research topic.  

Summary

This PA is expected to advance understanding of the nervous system through 
support of research, development, and enhancement of a wide range of 
neurotechnologies.  Examples of hardware, software, and wetware useful for 
neuroscience that would be considered appropriate under this PA for research, 
development and enhancement include but are not limited to:

o  Microelectromechanical system (MEMS) devices used for monitoring neuron 
function in slice and culture preparations

o  Amplifiers that are small and light enough to be worn by mice for 
recording neural activity from many neurons

o  Improved electrodes, microcomputer interfaces, and microcircuitry for 
chronic implantation, monitoring of neural activity, and promoting efferent 
function  

o  Dynamic monitors of intracranial pressure and cerebral spinal fluid 
composition (particularly important in following disease progression or 
recovery from brain injury) 

o  Devices for non-invasive diagnosis and precise identification of pathogens 
involved in central and peripheral neural infectious diseases

o  Tools for relatively non-invasive ways to assess damage and monitor 
function in regions of injured or diseased brain tissue

o  Proteome analysis arrays, proteome data storage and analysis of proteome 
data from the nervous system

o  Microfluidic systems for in-vivo spatial and temporal controlled delivery 
of neurotransmitters and other biomolecules

o  Delivery systems for exogenous agents such as drugs, gene transfer 
vectors, and cells

o  Non-invasive methods for in-vivo tracking of implanted cells

o  Tools for real-time analysis of neurophysiological events

o  Technologies for detection, intervention, and prevention of acute, adverse 
neurological events

o  Tools for early-warning detection of imminent seizure activity; 
application of targeted treatment to abort seizures 

o  Tools for therapeutic electrical stimulation for rehabilitation following 
stroke, trauma or other events or disorders that disrupt normal function of 
the nervous system

o  Telemetry devices small and light enough to be worn by mice for 
transmitting data (e.g., electrophysiological data) during behavior

o  Biosensors that would be selectively activated by neurochemicals, such as 
particular neurotransmitters or pharmacological compounds

o  Software to translate neuroimaging data from one data format into another

o  Tools for data mining for genetic discovery and functional insights into 
genomics and proteomics of the nervous system

o  Algorithms that use shape analysis approaches to understand human 
neuroimaging data

o  Tools to enhance visualization of specific brain markers

o  Computational approaches to analyzing video data (like those used in 
behavioral research)

o  Computational approaches and improved paradigms for analysis of kinematic 
data

o  Nanocrystals or quantum dots covalently bonded to neural receptor ligands 

o  Probes of brain gene expression that can be imaged non-invasively (e.g., 
with magnetic resonance or near infrared optical imaging)

It is stressed that the examples given above are not meant to be exhaustive, 
they are merely given to suggest the kinds of projects that would be 
appropriate.    

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of  
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at  
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at https://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines https://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format.  Although applicants are strongly encouraged to begin 
using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will 
continue to accept applications prepared using the 4/1998 revision until 
January 9, 2002.  Beginning January 10, 2002, however, the NIH will return 
applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301/710-0267, Email: 
GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (Type 1), 
competing continuation (Type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
https://grants.nih.gov/grants/guide/notice-files/not98-030.html.

INSTRUCTIONS SPECIFIC TO APPLICATIONS FOR SUPPORT OF TECHNOLOGY RESEARCH, 
DEVELOPMENT, OR ENHANCEMENT

Applications submitted in response to this program announcement may be 
design-, problem-, need-, or hypothesis-driven.  Thus, the application should 
state the hypotheses, designs, problems and/or needs that will drive the 
proposed research.  

As plans for technology research, development, and enhancement are augmented 
by specific feasibility tests of the technology and/or milestones, these 
should be presented in the Research Design and Methods section. 

Finally, applications should include a plan for making available to the 
research community the technologies developed or enhanced by grants funded 
under this PA; this should be described in the Research Design and Methods 
section of the application.  PHS policy requires that investigators make 
unique research resources readily available for research purposes to 
qualified individuals within the scientific community when they have been 
published (PHS Grants Policy statement in the July 12, 1996 issue of the NIH 
Guide to Grants and Contracts).  The intent of this policy, however, is not 
to not discourage, impede, or prohibit the organization that develops unique 
research resources or intellectual property from commercializing the 
products. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at 
https://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS

The Research Plan may not exceed 10 pages.

Item c, PRELIMINARY STUDIES/PROGRESS REPORT: Although preliminary data are 
not expected for an R21 grant application, if such data exist they should be 
presented.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened in accordance with 
the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the appropriate national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
method? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

o  The adequacy of the proposed plan for sharing or disseminating 
technologies developed or enhanced under this PA.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is available.

Direct inquiries regarding programmatic issues to:

Michael Huerta, Ph.D.
Division of Basic and Clinical Neuroscience Research
National Institute of Mental Health
6001 Executive Blvd. Room 7202, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 for express or courier service
Telephone:  (301) 443-3563  
FAX:  (301) 443-1731
Email:  mhuerta@helix.nih.gov

Lynn Luethke, Ph.D.
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-3458
FAX:  (301) 402-6251
Email:  lynn_luethke@nih.gov

Ralph Nitkin, Ph.D.
National Center for Medical Rehabilitation Research 
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-4206
FAX:  (301) 402-0832
Email:  rn21e@nih.gov

William J. Heetderks, M.D., Ph.D.
Repair and Plasticity
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd, Room 2207, MSC 9525
Bethesda, MD  20892-9525
Telephone:  (301) 496-1447
FAX:  (301) 480-1080
Email:  heet@nih.gov

Thomas G. Aigner, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 443-6975
FAX:  (301) 594-6043
Email:  ta17r@nih.gov

Bradley C. Wise, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda, MD  20892-9205
Telephone: (301) 496-9350
FAX:  (301) 496-1494
Email:  wiseb@nia.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Ms. Sara Stone
Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B
6120 Executive Boulevard, MSC-7180
Bethesda, MD  20892 
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  stones@nidcd.nih.gov

Mr. Christopher Myers
Grants Management Branch
National Institute for Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6996
Email:  cm143g@nih.gov

Ms. Brenda Kibler
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd, Room 3290, MSC 9537
Bethesda, MD  20892-9525
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  kiblerb@ninds.nih.gov

Gary Fleming, J.D.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@nia.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.242 (NIMH), 93.847 (NIDCD), 93.865 and 93.929 (NICHD), 93.853 (NINDS), and 
93.279 (NIDA).  Awards are made under authorization of sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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